Flushable disintegration catheter

ABSTRACT

Medical devices that are flushable in a standard toilet are disclosed. The medical devices are made at least in part of material that when introduced into water (of a toilet) disintegrate and/or fragment or are fragmentable before or after introduction into water such that they can be easily carried by the water through the disposal system. At least a portion of the device is intended for insertion into a patient or subject wherein the body-insertable portion retains its structural integrity while in use but is fragmentable once outside the body and exposed to a selected condition.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a U.S. national stage application of International PatentApplication No. PCT/US2014/069530, filed Dec. 10, 2014, which claims thebenefit of and priority to U.S. Provisional Patent Application Ser. Nos.61/915,311 and 61/915,396, both filed on Dec. 12, 2013, and U.S.Provisional Patent Application Ser. No. 62/011,337, filed Jun. 12, 2014,all of which are incorporated herein by reference in their entireties.

FIELD OF THE DISCLOSURE

The present disclosure is directed to medical devices such as urinarycatheters that after use may be disposed of by flushing down a toilet.More particularly, the present disclosure is directed to flushablecatheters which are fragmentable and/or disintegrable so as tofacilitate movement of the catheter through the sanitary system.

BACKGROUND

Intermittent catheters are commonly used by those who suffer fromvarious abnormalities of the urinary system, such as urinaryincontinence. Such catheters typically include an elongated shaft thatis inserted into and through the urethra to access the bladder. With theadvent of intermittent catheters, individuals with urinary systemabnormalities can self-insert and self-remove intermittent cathetersseveral times a day. Such catheters typically include a shaft made fromnon-biodegradable polymeric materials, such as non-biodegradablethermoplastics. One drawback associated with such non-biodegradablecatheters is that while they are intended for disposal, they are noteco-friendly in that the non-biodegradable materials of the catheter maytake several years to degrade.

Individuals who use intermittent catheters to drain their bladdersseveral times a day often use such catheters at home and in publicrestrooms. Intermittent catheterization involves inserting the elongatedshaft of the catheter through the urethra and into the bladder. Urine isdrained from the bladder through the catheter and into a wastereceptacle, such as a toilet or collection bag. After the bladder hasbeen drained, the catheter is typically disposed of in a solid wastecontainer. Often, particularly in a public restroom, it is difficult tofind a suitable waste container to discreetly dispose of the usedcatheter. In addition, if the user has to carry the catheter somedistance to a waste container, there may be some risk of leakage orspillage of bodily fluids. Moreover, the user may be uncomfortable orembarrassed by having to carry a used catheter to the waste container,particularly in public places. In such situations, the user may attemptto dispose of the catheter by flushing it down the toilet. Not allurinary catheters are compact or readily compactable. For example,urinary catheters used by males are substantially longer than those usedby females. An intermittent urinary catheter for an adult male can be aslong as 40 cm. Flushing such catheters down the toilet can causesignificant plumbing problems, such as clogging. Inasmuch as thecatheters are non-water disintegrable, flushing male or female urinarycatheters down the toilet also raises environmental concerns.

More recently, there has been increased interest in providing flushablecatheters which are made from materials that structurally disintegratewhen contacted with water, e.g., materials that are dissolvable,degradable and/or undergo hydrolysis. Such catheters are intended to beflushed down the toilet after use and dissolve, degrade or otherwisebreak down while passing through the sanitary system. Inasmuch asflushable catheters must at least substantially maintain structuralintegrity during use (i.e., during insertion into the urethra, drainageof urine and removal from the urethra), the water disintegrablematerials typically chosen are those with a slower degradation ordissolution rate and are such that the catheter does not substantiallydisintegrate until after being disposed of in the sanitary system forsome time. Thus, when a flushable catheter is placed within the toiletfor disposal, the structure of the catheter usually is stillsubstantially intact and will remain substantially intact duringflushing of the catheter for disposal thereof.

When a catheter is disposed of by flushing down a toilet, the force ofthe siphon and turbulent water current during flushing often may notcarry or move the catheter down the toilet and into the pipes of thesewer system and the catheter remains, as a whole, in the toilet bowlafter flushing. Additionally, because of the geometry of a typicalurinary catheter, the force or energy of the flushing water may notsufficiently impinge on the catheter to propel it down the toilet. Thismay be especially problematic with the now more common water conservinglow flush or low flow toilets. In such instances, the user may berequired to flush the toilet multiple times or just leave the catheterin the toilet, which may be embarrassing especially when using a publicrestroom.

Thus, while flushable catheters will eventually disintegrate (e.g.,dissolve, degrade or hydrolyze) after being placed within a toilet, itmay be difficult to physically flush the catheter down the toilet forany number of reasons, which may result in the catheter remaining in thetoilet bowl even after multiple flushes and ultimately causeembarrassment to the catheter user.

Accordingly, the present disclosure provides flushable urinary cathetersthat are disintegrable and also fragmentable, thereby allowing movementof the used catheter out of the toilet and through the sanitary systemduring flushing.

SUMMARY

In one aspect, the present disclosure is directed to a medical devicethat includes a body-insertable portion and a non-insertable portionwherein at least said body-insertable portion is made at least in partof a material selected to (a) retain the body-insertable portion intactwhen inserted within the body of a subject, and (b) fragment intomultiple pieces after the device has been removed from the body andexposed to a selected condition at the time of disposal.

In another aspect, the present disclosure is directed to a flushablemedical device system. The system includes a medical device assemblyincluding a body-insertable portion and a non-insertable portion. Atleast the body-insertable portion is made at least in part of a materialthat is fragmentable into multiple fragments under a selected condition.The system also includes an agent selected to promote fragmentation ofthe device.

In another aspect, the present disclosure is directed to a method ofdisposing a used medical device including a body-insertable portion anda non-insertable portion wherein at least said body-insertable portionis made at least in part of a material that is fragmentable intomultiple fragments. The method may include (a) contacting the usedmedical device with a solvent and (b) fragmenting the device intomultiple fragments.

In a further aspect, the present disclosure is directed to a method ofmaking a flushable medical device assembly. The method may includecompounding a water soluble material with a filler selected to releasethermal energy upon contact with water to provide a compounded material.The method may further include pelletizing the compounded material andmolding the compounded material into a desired component of a medicaldevice assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of a medical device, suchas a catheter, in accordance with the present disclosure;

FIG. 2 is a representative view of a medical device system, includingthe device, such as a catheter, in combination with an agent, wherebythe combination of a liquid and the agent provide an environment thatpromotes fragmentation;

FIG. 3 is a perspective view of an embodiment of a flushable cathetersystem in accordance with the present disclosure;

FIG. 4 is a perspective view of another embodiment of a flushablecatheter system in accordance with the present disclosure;

FIG. 5 is a perspective view of a further embodiment of a medicaldevice, such as a catheter, in accordance with the present disclosure;

FIG. 6 is a partial view of the medical device of FIG. 5;

FIG. 7 is a perspective view of the medical device of FIG. 5 in afragmented state;

FIG. 8 is a perspective view of another embodiment of a medical device,such as a catheter, in accordance with the present disclosure; and

FIG. 9 is a perspective view of the medical device of FIG. 8 in afragmented state.

DETAILED DESCRIPTION OF THE EMBODIMENTS

With reference to the Figures, FIGS. 1 and 2 show a medical device 10and/or a medical device system in accordance with the presentdisclosure. Although medical device 10 is shown in the context of acatheter assembly, such as urinary catheter, it will be understood thatthe following description finds application to other non-cathetermedical devices. In general, as shown in FIG. 1, medical device 10 mayinclude body-insertable portion 12 and non-insertable portion 14. Atleast the body-insertable portion 12 may be made of a material thatretains its structural integrity during use, i.e., the time during whichthe body-insertable portion 12 is inserted into and resides within thepatient or subject. Non-insertable portion 14, which as the namesuggests, is typically not inserted into the patient or subject, neednot (but may) be made of the same material used to make body-insertableportion 12.

Medical devices 10 of the type disclosed herein are preferably, but notnecessarily, devices that structurally break down when contacted bywater for convenient disposal through the sewer system. Medical devices(such as catheters) disclosed herein may be made from one or morematerials that are affected by a fluid (for example, water, urine orfluids utilized in toilet and plumbing systems). Such materials may bewater disintegratable or disintegrable materials. As used herein “waterdisintegratable” or “water disintegrable” materials refer to materialsthat are water soluble, water degradable, or water hydrolysable, andwhich dissolve, degrade, or otherwise break down when in contact withwater over a selected period of time. In other embodiments, the materialmay be enzymatically hydrolysable. The water disintegrable andenzymatically hydrolysable materials are preferably flushable materialswhich are suitable for disposal in a toilet or sanitary system and, evenmore preferably, biodegradable flushable materials which may bechemically broken down by living organisms or other biological means.

Such disintegrable or enzymatically hydrolysable materials may include,for example, certain forms of polyvinyl alcohol, including but notlimited to an extrudable polyvinyl alcohol, polyacrylic acids,polylactic acid, polyesters, polyglycolide, polyglycolic acid, polylactic-co-glycolic acid, polylactide, amines, polyacrylamides,poly(N-(2-Hydroxypropyl) methacrylamide), starch, modified starches orderivatives, amylopectin, pectin, xanthan, scleroglucan, dextrin,chitosans, chitins, agar, alginate, carrageenans, laminarin,saccharides, polysaccharides, sucrose, polyethylene oxide, polypropyleneoxide, acrylics, polyacrylic acid blends, poly(methacrylic acid),polystyrene sulfonate, polyethylene sulfonate, lignin sulfonate,polymethacrylamides, copolymers of aminoalkyl-acrylamides andmethacrylamides, melamine-formaldehyde copolymers, vinyl alcoholcopolymers, cellulose ethers, poly-ethers, polyethylene oxide, blends ofpolyethylene-polypropylene glycol, carboxymethyl cellulose, guar gum,locust bean gum, hydroxyproply cellulose shellac, vinylpyrrolidonepolymers and copolymers, polyvinyl pyrrolidone-ethylene-vinyl acetate,polyvinyl pyrrolidone-carboxymethyl cellulose, carboxymethyl celluloseshellac, copolymers of vinylpyrrolidone with vinyl acetate, hydroxyethylcellulose, gelatin, poly(ε-caprolactone), poly(p-dioxanone),polyhydroxyalkanoate, or combinations, blends or copolymers of any ofthe above materials. The water disintegratable materials may also be anyof those that are included in certified flushable products that meet theNational Sanitation Foundation standards for flushability or materialsand products that meet INDA/EDANA Flushability Guidelines or the UKWater Industry Research test protocols set forth in “Test Protocol toDetermine the Flushability of Disposable Products, Review of theManufactures 3^(rd) Ed. Guidance Document,” 2013, by Drinkwater et al.While catheters made from water disintegratable or enzymaticallyhydrolysable materials may be disposed of in a toilet, it is notnecessary to dispose of such catheters in a toilet and such cathetersmay also be disposed of in normal municipal waste systems or garbagecollection systems.

Flushable devices of the type described herein may have a selecteddensity. For example, it may be preferred for the medical device 10(such as catheter assembly) and/or its individual components (includingthe catheter shaft, funnel, and introducer cap assembly) to have adensity in the range of approximately 0.40 g/cc to approximately 1.2g/cc, although it is also within the scope of the present disclosure forthe catheter assembly or one or more of its individual components tohave a density that is outside of this range.

In one embodiment, both body-insertable portion 12 and non-insertableportion 14 are preferably made of material that is water-disintegrablewhen exposed to water for a period of time, although non-disintegrablematerials may be used as well in certain circumstances.

In an example where medical device 10 is a catheter, as shown in FIG. 1,body-insertable portion 12 is preferably the elongated shaft that isinserted into the urethra of the patient. Shaft 12 includes anelongated, hollow, typically polymeric tube that defines a flow paththerethrough. As shown in FIG. 1, body-insertable portion 12 (e.g.,catheter shaft) includes apertures or eyelets 16 through which urineenters the catheter. Urine flows through shaft 12 toward a funnel 14 a,which is in flow communication with the flow path of shaft 12. Funnel 14a, which is typically considered a non-insertable portion 14, may beflared with an opening at its distal end for directing fluid into awaste receptacle such as a toilet or to which a plastic urine collectioncontainer may be attached.

In accordance with the present disclosure, in addition to beingwater-disintegrable, at least a portion of medical device 10 may befragmentable. More particularly, at least the material used to makebody-insertable portion 12 may further include a chemical compound oragent that (1) while the catheter is in use, namely within the urethralcanal of the patient, it at least substantially retains its structuralintegrity and remains intact, (2) but upon exposure to (one or more of)a selected condition outside the body of the subject will fragment. Inone embodiment, the selected conditions may be the application ofphysical force to the medical device that causes fragmentation of thedevice prior to its introduction into the waste receptacle. In anotherembodiment, the selected condition may be exposure to a liquid at aselected pH. In an alternative embodiment, or in addition to theconditions described above, the selected condition may be one in whichan effervescent or otherwise mildly turbulent environment is provided topromote the fragmentation and/or disintegration of device 10. Inaccordance with another embodiment, the selected condition may beexposure of device 10 to liquid at an elevated temperature. Inaccordance with the present disclosure, medical device 10 will notfragment until the body-insertable portion 12 of device 10 has beenremoved from the patient and the selected condition is established.

In an embodiment, medical device 10 may be provided in a medical devicesystem that further includes an agent selected to promote fragmentationand/or establish the selected condition. The selected agent may be onethat affects the pH of the liquid (e.g., water) inside the wastereceptacle/toilet. Alternatively, or in addition, the agent may also beone that affects the temperature of the liquid. In a further alternativeor in addition to the foregoing, the agent may be one that creates aneffervescent or otherwise mildly turbulent environment that will promotedisintegration.

For example, in one embodiment, the agent may be a catalyst that affectsthe pH of a liquid (e.g., water) in the waste receptacle (e.g., toilet).In a more specific embodiment, the agent may lower the pH of the waterbelow its original pH and/or below a pH of about 7. In the presence ofwater/liquid of a lowered the pH, the material selected for medicaldevice 10 which includes a selected chemical compound or other agentwill react and, for example, create gas bubbles on the surface of thedevice. The bubbles create a mildly turbulent or effervescentenvironment which promotes the breakup of the medical device 10,resulting in multiple device fragments which are easier to flush.

As shown in FIG. 2, in one embodiment, agent/catalyst 19 may be providedas a tablet 20, whereas in other embodiments, the agent/catalyst 19 maybe provided in another form that provides the selected condition, i.e.pH adjustment, temperature adjustment, etc. Tablet 20 may be providedwith the packaged medical product and introduced into the liquidreceptacle at the time of device disposal. Alternatively, theagent/catalyst 19 may be provided as part of medical device 10 that isintegral with and/or removable from device. For example, in the case ofa urinary catheter as shown in FIG. 3, agent/catalyst may be dispersedor otherwise incorporated in funnel 14 a that is integral with elongatedshaft 12 of catheter/device 10. Upon contact with water, thenon-insertable portion 14 releases the agent/catalyst 19. In anotherembodiment, agent/catalyst 19 may be included or otherwise incorporatedinto removable cap 14 b commonly used in intermittent urinary catheters,as also shown specifically in FIG. 3. In yet a further embodiment,agent/catalyst 19 may be provided in a sachet or disintegrable pouchincluded and packaged with medical device. In a further embodiment,agent/catalyst 19 may be part of the material of package 22 that housesdevice 10, as shown in FIG. 4. In this case, package 22 may alsolikewise be made of a disintegrable material. Introduction of the entirepackage 22 into the water-containing waste receptacle results in therelease of agent/catalyst 19 and promotes or otherwise creates theselected condition desired to promote fragmentation of medical device10.

In an embodiment, agent/catalyst 19 and the material selected formedical device 10 (and/or package 22), when combined with water 21 (seeFIG. 2), react to create the selected condition that promotesdisintegration and/or fragmentation of medical device 10. For example inone embodiment, device 10 may be made of a material that includes acompound that will react with water in the presence of an agent/catalyst19 of the type described above. It is not necessary that the entiredevice 10 be made of the compound. In one embodiment, device 10(including the body-insertable portion 12 and non-insertable portion 14)may be made of generally disintegrable material of the type describedabove that is blended or otherwise combined with the compound selectedto react directly or indirectly with agent/catalyst 19 and allow forfragmentation and/or disintegration of medical device 10. The compoundmay be included in both the body-insertable portion 12 andnon-insertable portion 14. The compound 18 may be dispersed (uniformlyor randomly) throughout the material of one of or both ofbody-insertable portion 12 and non-insertable portion 14, as shown inFIGS. 1-4.

In an embodiment, the compound that is dispersed throughout the materialof device 10 may be one that reacts (in some manner) when exposed to theselected condition of a certain pH, while not substantially reactingwhen exposed to the pH environment of that part of the body into whichdevice 10 is introduced. Thus, the body-insertable portion 12 of device10 remains intact while inside the body of the subject or patient anddoes not fragment in the pH environment of the body canal during thetime of treatment. In accordance with typical self-catheterizationprocesses, the material should remain intact for up to approximately 10minutes. The reaction may be one that causes direct disintegrationand/or fragmentation of medical device 10 and or one that creates anenvironment that promotes fragmentation such as the effervescentenvironment described above.

In one example of the medical device in accordance with the presentinvention disclosure, the material used for the medical device, such ascatheter 10, may include a blowing agent or a chemical that reacts withselected agent/catalyst 19 or the selected condition generated by theagent/catalyst 19 (FIGS. 1-4). In a specific example, the chemicalcompound may be sodium bicarbonate which is introduced and dispersedeither randomly or uniformly throughout the walls of device 10 and, moreparticularly, throughout insertable body portion 12 and optionallynon-insertable portion 14. A suitable agent/catalyst 19 may therefore beone that affects the pH of the liquid (water) in the liquid receptacleby lowering the pH, causing a reaction between the acidified liquid andthe sodium bicarbonate dispersed in the wall(s) of medical device 10.The reaction between the agent/catalyst 19, the liquid medium (water),and the sodium bicarbonate of the device will generate a bubbling oreffervescent environment that will promote disintegration and breakup ofmedical device 10 into smaller fragments. An example of a suitableagent/catalyst 19 that may be used to promote fragmentation of medicaldevice 10 without damaging the environment may be a mild acidic compoundsuch as acetic acid.

In another embodiment, medical device 10, such as a urinary catheter,may include or be made of a composite material of a water solublepolymer containing a filler/plasticizer material. The filler/plasticizermaterial, when in contact with water, dissolves and releases heat.Therefore, when device 10 is introduced into the toilet and contacts thewater, the filler/plasticizer releases heat, accelerating thedissolution rate of the composite material, promoting disintegration andfacilitating its flushability. In one embodiment, filler/plasticizer maybe substantially uniformly distributed throughout device 10. In anotherembodiment, filler/plasticizer may be concentrated in selected portionsof device 10, thereby concentrating the release and action of thermalenergy at selected points along device 10. The higher concentration offiller/plasticizer and localized action of the thermal energy mayprovide for fragmentation of device 10 at the selected portions, asdescribed elsewhere in the present disclosure.

For most materials, the diffusion rate increases with temperature. Thedissolution of the filler/plasticizer and the thermal energy releasedpreferably occur within a certain time scale. Thus, fillers/plasticizerswith high exothermic dissolution enthalpy, but that dissolve very slowlymay be less desirable. Additionally, fillers with high exothermicdissolution enthalpy but that dissolve too fast may likewise be lessdesirable, as they may release the thermal energy while in contact withthe urine when the bladder is being emptied.

Examples of suitable fillers that may be used in medical device 10 ofthis embodiment include, but are not limited to, aluminum bromide,aluminum chloride, aluminum fluoride, aluminum iodide, aluminum sulfate,beryllium bromide, beryllium chloride, beryllium iodide, berylliumsulfate, cadmium sulfate, calcium bromide, calcium iodide, chromouschloride, cobaltous bromide, cobaltus iodide, cobaltus sulfate, cupricnitrate, ferric chloride, ferrous bromide, ferrous iodide, ferroussulfate, lithium bromide, lithium iodide, lithium chloride, magnesiumbromide, magnesium chloride, magnesium iodide, magnesium sulfate,magnesium sulphide, manganic sulfate, manganous acetate, manganousbromide, manganous chloride, manganous iodide, nickel bromide, nickelchloride, nickel iodide, nickel nitrate, nickel sulphate, potassiumaluminum sulfate, potassium chromium sulphate, potassium hydroxide,sodium hydroxide, sodium sulfide, strontium iodide. Other organic andinorganic solids and their corresponding enthalpies of dissolution canbe found in Perry's Chemical Engineer Handbook, which is incorporatedherein by reference.

In another embodiment, the use of less expensive fillers (as compared tosome of the polymers described above) that typically do not result inthe release of thermal energy, and foaming agents such as air, may allowfor a further reduction in manufacturing costs. Examples of such lessexpensive fillers that typically do not result in the release thermalenergy include, but are not limited to, non-water soluble compounds suchas calcium carbonate and some forms of cellulose, and water-solublecompounds such as sodium chloride.

Medical devices (e.g., catheters) utilizing a water-soluble polymer andfiller/plasticizer may be manufactured by, for example, (1) compoundinga water soluble polymer with the filler/plasticizer using a twin screwextruder, (2) pelletizing the compounded material and (3) injectionmolding the compounded material into a molded component of the device,such as a catheter funnel. These polymer processes involve heating thepolymer above its melting temperature. Accordingly, the resultingmaterial must have suitable physical, chemical and biological propertiessuch that it can be used to make urinary catheters, their package andcomponents of a flushable, ready-to-use catheter.

In one embodiment where the compounded material is molded into acatheter funnel, the funnel may be made of a foam material that includes50% (by volume) gas, such as air, 40% filler (such as aluminum sulfate),and 10% polyvinyl alcohol (PVOH). Such 50%/40%/10% composite asdescribed above may dissolve faster than, for example, the same funnelmade of 100% PVOH, because of the presence of filler. A 20%:50%:30%composite may also be suitable for a flushable medical device asdescribed herein.

In another embodiment, the filler material need not be incorporated intoa component but may be placed in a small PVOH sachet that is thenintroduced into the toilet at the same time as the catheter is beingflushed. In this embodiment the sachet dissolves, water contacts thefiller, and heat is released, increasing the temperature of the toiletwater in which the catheter is disposed prior to flushing the device.

In another embodiment, as shown in FIGS. 5-9, medical device 100 mayinclude fracture points 28 at which the device collapses or fragments.Fracturing at fracture points may be induced under a selected condition.The selected condition may be mechanical, physical, chemical, manual ora combination of two or more such conditions. In one embodiment, medicaldevice 100 (such as the catheter depicted in FIGS. 5-7) may includefibers 24 that may be embedded in the wall of device 100. Fragmenting orthe breakup of medical device 100 (e.g., catheter 100) makes it easierto flush the used medical device 100 down the toilet and through pointsof constriction in a plumbing system (e.g., U-bend). In the example ofFIGS. 5-7, medical device 100 may include fibers 24 embedded within thebody of device 100 and more specifically in the body-insertable portion112 (i.e., the catheter shaft). In a specific embodiment, fibers 24 mayextend along the entire length of device 100 and, more specifically,body-insertable portion 112. Fibers 24 may be provided with pull tabs 26located at or near the distal end of the elongated catheter, such as,for example, near funnel 114 a. Tabs 26 allow the user to handle medicaldevice 100 in a hygienic manner.

In the embodiment of FIGS. 5-7, fibers 24 may further be concentrated ormay converge at selected points of device 100 and more specifically ofbody-insertable portion 112. For example, where medical device 100 is acatheter (as depicted) fibers 24 may be concentrated at fracture points28 at selected and spaced points along the length of body-insertableportion 112. When tabs 26 are pulled, fibers 24 are necessarily pulledaway from the body of the body-insertable portion 112, thereby causing ashredding and ripping of body-insertable portion 112. This, in turn maycause body-insertable portion 112, i.e., the catheter shaft, of breakinginto pieces or fragments 29, as shown in FIG. 7.

Alternatively, fracture points 28 may be provided as thin-walled and/orbrittle regions of medical device 100. Making these fracture points 28thinner and/or brittle provides for manual fragmentation ofbody-insertable portion 112. Thus, in one embodiment medical device 100may be manually and bare handedly fragmented by the user at the thinnerand/or brittle fracture points prior to placement in the wastereceptacle such as a toilet. The medical device may additionally butoptionally be provided with a tool for pressing or severing device 100at the fracture points prior to disposal in the waste receptacle ortoilet bowl.

In another embodiment shown in FIGS. 8-9, fracture points 228 may beregions that include a higher concentration of a readily water solublepolymer material. The remainder of device 200 may be made of a materialhaving solubility characteristics different from fracture points 228and, thereby, dissolve at a much slower rate. This may allow device 200to maintain its required mechanical properties and structural integrityduring use, while allowing device 200 to break up or effectively melt atpredefined points as soon as it comes into contact with the water. Inaddition, fracture points 228 may be selected on the basis that theywill be less likely to have water exposure when in use by the patientbut more likely to get wetted and break up or dissolve immediately oralmost immediately when placed in the toilet bowl.

In another embodiment, fracture points 228 may be provided as regionspre-loaded with a chemical that reacts when it contacts water in thetoilet. For example, fracture points 228 may be pre-loaded with achemical compound such as sodium bicarbonate or a blowing agent. Inaccordance with previously described embodiments, acetic acid, or tablevinegar, or another acidic agent may be added to the toilet water toaccelerate the break-up of the catheter at these points into fragments229 when the sodium bicarbonate or other compounds react with theacidified water. The device 100 or 200 maintains its required mechanicalproperties and structural integrity during the treatment period when itresides within the patient, while allowing it to break-up or fragment atpredefined points when placed in contact with water (in the toiletbowl.)

The embodiments disclosed herein facilitate discrete disposal of a usedmedical device (and optionally its associated packaging) in a toiletwithout leaving waste in the trash bin. This may be particularlydesirable when users catheterize in public toilet facilities or in thetoilet facilities of family and friends. Catheters of the type describedherein also reduce the level of physical difficulty for disposal ofmaterials used at the end of the procedure.

Other Aspects

In a first aspect, a medical device including a body-insertable portionand a non-insertable portion is provided. At least the body-insertableportion is made at least in part of a material selected to (a) retainthe body-insertable portion intact when inserted in the body of thesubject, and (b) fragment into multiple pieces when outside the body andunder a selected condition.

A second aspect of the present subject matter includes the medicaldevice in accordance with the first aspect wherein the selectedcondition comprises contact with water.

A third aspect of the present subject matter includes the medical devicein accordance with any one of the first or second aspects wherein theselected condition comprises the presence of an agent selected topromote disintegration of at least the body-insertable portion.

A fourth aspect of the present subject matter includes the medicaldevice in accordance with the third aspect wherein the agent is separatefrom the device.

A fifth aspect of the present subject matter includes the medical devicein accordance with the third aspect wherein the non-insertable portioncontains the agent.

A sixth aspect of the present subject matter includes the medical devicein accordance with any one of the first through fifth aspects whereinthe selected material includes a chemical compound dispersed throughoutat least the body-insertable portion.

A seventh aspect of the present subject matter includes the medicaldevice in accordance with any one of the first through sixth aspectswherein the compound is sodium bicarbonate.

An eighth aspect of the present subject matter includes the medicaldevice in accordance with any one of the first through sixth aspectswherein the selected condition comprises a liquid solvent having a pH ofless than approximately 7.0.

A ninth aspect of the present subject matter includes the medical devicein accordance with any one of the first through seventh aspects whereinthe selected condition comprises an effervescent liquid environment.

A tenth aspect of the present subject matter includes the medical devicein accordance with any one of the first through eighth aspects whereinthe selected condition comprises a liquid of increasing temperature.

An eleventh aspect of the present subject matter includes the medicaldevice in accordance with the first aspect wherein at least thebody-insertable portion comprises a plurality of fibers embeddedtherein.

A twelfth aspect of the present subject matter includes the medicaldevice in accordance with the eleventh aspect wherein the medical deviceincludes pull tabs associated with the fibers.

A thirteenth aspect of the present subject matter includes the medicaldevice in accordance with any one of the first through twelfth aspectswherein the body-insertable portion comprises fracture points.

A fourteenth aspect of the present subject matter includes the medicaldevice in accordance with the thirteenth aspect wherein the fracturepoints include a material different from the selected material.

A fifteenth aspect of the present subject matter includes the medicaldevice in accordance with any one of the thirteenth or fourteenthaspects wherein the fracture points have a solubility that is differentfrom the solubility of the remainder of the body-insertable portion.

A sixteenth aspect of the present subject matter includes the medicaldevice in accordance with any one of the thirteenth through fifteenthaspects wherein the fracture points have a thickness different from thethickness of the remainder of the body-insertable portion.

A seventeenth aspect of the present subject matter includes the medicaldevice in accordance with any one of the first through sixteenth aspectswherein the non-insertable portion comprises a material selected tofragment into multiple pieces when under the selected condition.

In an eighteenth aspect a method of disposing of a used medical deviceis provided. The medical device includes a body-insertable portion and anon-insertable portion wherein at least the body-insertable portion ismade at least in part of a material that is fragmentable. The methodincludes (a) contacting the device with a solvent and (b) fragmentingthe device into multiple fragments.

A nineteenth aspect of the present subject matter includes the method inaccordance with the eighteenth aspect comprising fragmenting the deviceprior to contacting.

A twentieth aspect of the present subject matter includes the method inaccordance with any one of the eighteenth or nineteenth aspectscomprising fragmenting the device at selected fracture points along thebody-insertable portion.

A twenty-first aspect of the present subject matter includes the methodin accordance with any one of the eighteenth through twentieth aspectscomprising combining the device with a catalyst.

A twenty-second aspect of the present subject matter includes the methodin accordance with the twenty-first aspect comprising adding thecatalyst to the solvent before or after contacting.

A twenty-third aspect of the present subject matter includes the methodin accordance with any one of the eighteenth through twenty-secondaspects further comprising creating an effervescent environment.

A twenty-fourth aspect of the present subject matter includes the methodin accordance with any one of the eighteenth through twenty-thirdaspects comprising raising the temperature of the solvent.

A twenty-fifth aspect of the present subject matter includes the methodin accordance with any one of the eighteenth through twentieth aspectswherein the device comprises points of weakness distributed throughoutat least the body-insertable portion.

A twenty-sixth aspect of the present subject matter includes the methodin accordance with any one of the eighteenth through twenty-fifthaspects comprising removing embedded fibers from the device.

In a twenty-seventh aspect, a flushable medical device system isprovided. The medical device system includes a medical device assemblyincluding a body-insertable portion and a non-insertable portion whereinat least the body-insertable portion is made at least in part of amaterial that is fragmentable into multiple fragments, and an agentselected to promote fragmentation of the device.

A twenty-eighth aspect of the present subject matter includes theflushable medical device system in accordance with the twenty-seventhaspect wherein the agent is a compound that reacts with the material.

A twenty-ninth aspect of the present subject matter includes the systemin accordance with the twenty-seventh aspect wherein the agent is acompound that reacts with a liquid.

A thirtieth aspect of the present subject matter includes the system inaccordance with the twenty-ninth aspect wherein the liquid is water.

A thirty-first aspect of the present subject matter includes the systemin accordance with any one of the twenty-seventh through thirtiethaspects wherein the agent comprises an acid.

A thirty-second aspect of the present subject matter includes the systemin accordance with any one of the twenty-seventh through thirtiethaspects wherein the agent is selected to raise the temperature of theliquid.

A thirty-third aspect of the present subject matter includes a system inaccordance with any one of the twenty-seventh through thirtieth aspectswherein the agent is provided in the form of a tablet.

A thirty-fourth aspect of the present subject matter includes the systemin accordance with any one of the twenty-seventh through thirtiethaspects wherein the agent is provided in a part of the device assembly.

A thirty-fifth aspect of the present subject matter includes the systemin accordance with any one of the twenty-seventh through thirty-fourthaspects further comprising a package wherein the agent is provided inthe package.

A thirty-sixth aspect of the present subject matter includes the systemin accordance with any one of the twenty-seventh through thirty-fifthaspects wherein at least the body-insertable portion comprises sodiumbicarbonate.

In a thirty-seventh aspect, a method of making a flushable medicaldevice assembly is provided. The method includes (a) compounding a watersoluble material with a filler selected to release thermal energy uponcontact with water to provide a compounded material, (b) pelletizing thecompounded material, and (c) molding the compounded material into adesired component of a medical device assembly.

A thirty-eighth aspect of the present subject matter includes the methodin accordance with the thirty-seventh aspect further comprisingincorporating the molded component into the medical device.

A thirty-ninth aspect of the present subject matter includes the methodin accordance with any one of the thirty-seventh or thirty-eighthaspects wherein the water soluble material is heated to a temperatureabove its melting point.

A fortieth aspect of the present subject matter includes the method inaccordance with any one of the thirty-eighth or thirty-ninth aspectswherein the desired component comprises a foam material.

A forty-first aspect of the present subject matter includes the methodin accordance with the fortieth aspect wherein the material comprisesabout 50% gas by volume.

A forty-second aspect of the present subject matter includes the methodin accordance with the forty-first aspect wherein the desired componentfurther comprises a polymeric material.

A forty-third aspect of the present subject matter includes the methodin accordance with the forty-second aspect wherein the polymericmaterial comprises polyvinyl alcohol.

A forty-fourth aspect of the present subject matter includes the methodin accordance with any one of the fortieth through forty-third aspectswherein the desired component comprises a foam comprising gas, filler,and a polymer in a ratio of 20:30:50.

A forty-fifth aspect of the present subject matter includes the methodin accordance with any one of the thirty-seventh through forty-fourthaspects wherein the medical device is a urinary catheter, the methodcomprising molding the compounded material into a catheter funnel.

The invention claimed is:
 1. A medical device comprising anon-insertable portion and a fragmentable shaft having a single lumen,wherein the shaft includes a body-insertable portion having a lengthwherein at least said body-insertable portion is made at least in partof a material selected to retain said body-insertable portion intactwhen inserted in the body of a subject and wherein said body-insertableportion comprises multiple fracture points spaced from one another alongthe length of the shaft to allow at least said body-insertable portionto fracture into multiple pieces of said shaft along the length of atleast said body insertable portion when outside said body and under aselected condition.
 2. The medical device of claim 1 wherein saidselected condition comprises contact with water.
 3. The medical deviceof claim 1 where said selected condition comprises the presence of anagent selected to promote disintegration of at least saidbody-insertable portion.
 4. The device of claim 3 wherein said agent isseparate from said device.
 5. The device of claim 3 wherein saidnon-insertable portion contains said agent.
 6. The device of claim 1wherein said selected material includes a chemical compound dispersedthroughout at least said body-insertable portion.
 7. The device of claim1 wherein said selected condition comprises a liquid solvent having a pHof less than approximately 7.0.
 8. The device of claim 1 wherein saidselected condition comprises an effervescent liquid environment.
 9. Thedevice of claim 1 wherein said selected condition comprises a liquid ofincreasing temperature of a liquid with which said medical device is incontact when outside said body.
 10. The device of claim 1 wherein atleast said body-insertable portion comprises a plurality of fibersembedded therein.
 11. The device of claim 1 wherein said fracture pointsinclude a material different from said selected material.
 12. The deviceof claim 1 wherein said fracture points have a solubility different fromthe solubility of the remainder of said body-insertable portion.
 13. Thedevice of claim 1, wherein the body insertable portion of the shaftcomprises a single continuous flow path that is broken intodiscontinuous flow path segments when the body insertable portion isfragmented.
 14. The device of claim 1, wherein the at least saidbody-insertable portion fractures into multiple shorter pieces of saidshaft along the length of at least said body insertable portion whenoutside said body and under a selected condition.